← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K964243 # HUMERUS WIRES (K964243) _Compagnie Financiere & Medicale (Cf&M) · HSB · Dec 5, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K964243 ## Device Facts - **Applicant:** Compagnie Financiere & Medicale (Cf&M) - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Dec 5, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Humerus Wires device is intended to be implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone. ## Device Story Internal wire fixation device; used for humeral fracture fixation and bone reconstruction. Implanted in humerus; provides structural support. Operated by orthopedic surgeons in clinical/surgical settings. Device design similar to existing fixation pins/wires; lacks locking screw mechanism. Benefits patient by stabilizing humeral fractures to facilitate healing. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and material similarity to predicate devices. ## Technological Characteristics Internal wire fixation device. Manufactured from materials previously utilized in FDA-cleared medical devices. Design is a smooth fixation pin/wire. Non-locking configuration. ## Regulatory Identification An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. ## Predicate Devices - Applied Osteo Systems True/Flex IM Rod System for the Humerus, Radius, and Ulna ([K902264](/device/K902264.md), [K913949](/device/K913949.md)) - Richards Ender Pins ([K811002](/device/K811002.md)) - O'Tec Corporation Rush Pins ([K905341](/device/K905341.md)) - Onyx Corporation Rush Pins ([K903261](/device/K903261.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FERGUSON MEDICAL 916-342-4133 FAX: 916-343-4541 20 September 1996 DEC - 5 1996 K964243 510(k) SUMMARY The 510(k) summary information required by CFR 807.92 is as follows: A. Classification name: Pin, fixation, smooth Common/usual name: Fixation wire, fixation pin, nail, rod, and others Proprietary name: Humerus Wires B. Substantial equivalence: Applied Osteo Systems True/Flex IM Rod System for the Humerus, Radius, and Ulna (K902264, K913949), Richards Ender Pins (K811002), O'Tec Corporation and Onyx Corporation Rush Pins (K905341 and K903261, respectively), and others. C. Device description: The Humerus Wires device is an internal wire fixation device to be used in the fixation of humeral fractures. D. Intended use: The Humerus Wires device is intended to be implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone. E. Technological characteristics: The Humerus Wires 3407 Bay Avenue • Chico, California 95973 • USA {1} device is similar to predicate devices in its design, function, and intended use. The device is similar to certain predicates which do not utilize a locking screw, but it is unlike predicates which do utilize such a locking component. The Humerus Wires device is manufactured from materials presently and/or previously utilized in FDA-cleared medical devices. Submitted, FERGUSON MEDICAL FDA Establishment Registration Number 2937794 Frank Ferguson Official Correspondent --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K964243](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K964243) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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